The Cascadia lateral interbody system (K2M) has been granted 510(k) marketing clearance from the US Food and Drug Administration (FDA). The system features K2M’s proprietary, 3D-printed Lamellar Titanium technology, which is designed to allow for bony integration throughout an implant. The system has also received a CE mark.
The Lamellar Titanium technology uses a 3D printing method to create previously-impracticable structures. Starting with a titanium powder, the implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that pre-clinical data have associated with bone growth activity.
“By incorporating the porosity and rough surfaces of the Lamellar Titanium technology into the Cascadia lateral interbodies, an alternative now exists to the traditional PEEK and Titanium cages commonly used in direct lateral fusion procedures,” states Pierce Nunley, director of the Spine Institute of Louisiana, who completed the first surgical case using Cascadia lateral in December 2015. “The design of the Cascadia lateral implant offers me a greater bone graft volume than my normal Aleutian PEEK implant, while increasing the endplate contact surface area and still allowing me the ability to radiographically evaluate the fusion.”
K2M’s Lamellar Titanium technology incorporates titanium with a surface roughness of 3-5 microns and is designed to allow for direct bony ongrowth. The technology also incorporates 500 micron longitudinal channels throughout the implant which, in conjunction with traverse windows, create an interconnected lattice designed to allow for bony integration. Lamellar Titanium technology exploits the material properties of titanium, in conjunction with a product design that incorporates an approximately 70% porosity to mitigate the device’s radiographic signature.
The Cascadia lateral interbody system features a reverse hourglass implant design that is intended to allow for increased endplate contact compared to an Aleutian implant, without sacrificing internal bone graft volume. The system includes a full range of implant sizes and is designed to work in conjunction with the Ravine lateral access system, offering a full line of instrumentation for the far lateral transpsoas approach.
“We are pleased to receive FDA 510(k) clearance and a CE mark for the Cascadia lateral interbody system, further expanding the offering of our proprietary Lamellar Titanium technology, which uses 3D printing, and is designed to allow for bony ongrowth and ingrowth,” states Eric Major, K2M’s president and CEO.